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Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis

Primary Purpose

Japanese Encephalitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Mouse brain derived japanese encephalitis vaccine (MB-JEV)

Primary and booster immunizations with MB-JEV

C) primary immunizations with Ixiaro

S) Ixiaro booster to MBJEV primed

About this trial

This is an interventional prevention trial for Japanese Encephalitis focused on measuring Ixiaro, japanese encephalitis vaccine, booster

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Male and female travellers ≥ 18 years of age.
- General good health.
- Written informed consent.
- Ability to attend all visits scheduled in this study.
- Travellers who have previously got a primary vaccination series of 2 or 3 doses of JE-MB and now receive a booster vaccination , either MB-JEV or IXIARO, at the travel clinic for their journey to Asia, OR
- Travellers with no previous vaccination against JE who are given the primary vaccination series with IXIARO at a travel clinic prior to their journey to Asia.

Exclusion Criteria:

- < 18 years of age.
Acute disease at the time of enrollment.
Pregnancy or lactation.
Known immunodeficiency or immune suppressive treatment.
Any chronic illness that might interfere with the immune response; history of JE.
Alcohol or drug abuse.
Any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

A) primary immunization with MB-JEV

Primary and booster MBJEV vaccinations

C) primary immunizations with Ixiaro

S) Ixiaro booster to MBJEV primed

Arm Description

Volunteers immunized with MB-JEV

Booster immunization with MB-JEV of vaccinees primed with MB-JEV

Primary immunization with Ixiaro 2 dose

Actual study group:Booster immunization with Ixiaro to those primed previously with MB-JEV

Outcomes

Primary Outcome Measures

Antibody titers 1 month after last vaccine dose

Determination of antibody titers 1 month after last vaccine dose

Secondary Outcome Measures

Antibody titers two years after vaccination

Measurement of antibody titers two years after vaccination

Full Information

NCT ID

NCT01386827

First Posted

June 30, 2011

Last Updated

October 27, 2011

Sponsor

Helsinki University Central Hospital

Collaborators

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT01386827

Brief Title

Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis

Official Title

Ability of the New Vero-cell-derived Inactivated Japanese Encephalitis Vaccine (IXIARO) to Elicit a Booster Response in Travellers Previously Vaccinated With Traditional Mouse-brain Derived Vaccine (JE-MB)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helsinki University Central Hospital

Collaborators

Karolinska Institutet

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The old mouse brain derived Japanese encephalitis vaccines (MBJEV) have been reported to cause serious adverse effects and are therefore replaced with the novel Ixiaro vaccine. The present study investigates whether vaccinees primed with MBJEV can be boosted with Ixiaro. Travellers receiving Japanese encephalitis vaccines are enrolled for a follow-up of immune responses in four groups: A) primary immunization with BMJEV, B) primary and secondary immunizations with MBJEV, C) primary immunizations with Ixiaro and S) Primary immunization with MBJEV and secondary immunization with Ixiaro. Immune responses are followed with help of serum samples collected before and after vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Japanese Encephalitis

Keywords

Ixiaro, japanese encephalitis vaccine, booster

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A) primary immunization with MB-JEV

Arm Type

Active Comparator

Arm Description

Volunteers immunized with MB-JEV

Arm Title

Primary and booster MBJEV vaccinations

Arm Type

Active Comparator

Arm Description

Booster immunization with MB-JEV of vaccinees primed with MB-JEV

Arm Title

C) primary immunizations with Ixiaro

Arm Type

Active Comparator

Arm Description

Primary immunization with Ixiaro 2 dose

Arm Title

S) Ixiaro booster to MBJEV primed

Arm Type

Active Comparator

Arm Description

Actual study group:Booster immunization with Ixiaro to those primed previously with MB-JEV

Intervention Type

Biological

Intervention Name(s)

Mouse brain derived japanese encephalitis vaccine (MB-JEV)

Other Intervention Name(s)

Korean Green Cross

Intervention Description

a) 2-3 doses of MB-JEV vaccine 0.5ml given on day 0, 7, 30 immunization and one booster dose of Ixiaro 0.5 ml > 2 years later

Intervention Type

Biological

Intervention Name(s)

Primary and booster immunizations with MB-JEV

Other Intervention Name(s)

Korean Green Cross

Intervention Description

2-3 doses of MB-JEV vaccine 0.5ml given on day 0, 7, 30 as primary immunization and one booster dose of 0.5 ml > 2 years later

Intervention Type

Biological

Intervention Name(s)

C) primary immunizations with Ixiaro

Other Intervention Name(s)

Ixiaro

Intervention Description

2 0.5 ml doses of Ixiaro 28 days apart

Intervention Type

Biological

Intervention Name(s)

S) Ixiaro booster to MBJEV primed

Other Intervention Name(s)

Ixiaro

Intervention Description

0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV

Primary Outcome Measure Information:

Title

Antibody titers 1 month after last vaccine dose

Description

Determination of antibody titers 1 month after last vaccine dose

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Antibody titers two years after vaccination

Description

Measurement of antibody titers two years after vaccination

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female travellers ≥ 18 years of age. General good health. Written informed consent. Ability to attend all visits scheduled in this study. Travellers who have previously got a primary vaccination series of 2 or 3 doses of JE-MB and now receive a booster vaccination , either MB-JEV or IXIARO, at the travel clinic for their journey to Asia, OR Travellers with no previous vaccination against JE who are given the primary vaccination series with IXIARO at a travel clinic prior to their journey to Asia. Exclusion Criteria: - < 18 years of age. Acute disease at the time of enrollment. Pregnancy or lactation. Known immunodeficiency or immune suppressive treatment. Any chronic illness that might interfere with the immune response; history of JE. Alcohol or drug abuse. Any clinically significant history of known or suspected anaphylaxis or hypersensitivity (based on the investigator's judgement).

Overall Study Officials: